An important aspect of ensuring patient safety centres around medicines product information and promotion (including advertising), via patient information leaflets (PILs) / package leaflets (PLs), labelling and Summaries of Product Characteristics (SmPCs), which provide details on how the medicine can be used.
Artwork and labelling have a significant role in the marketing of Healthcare products. The regulation of advertising, labelling and package leaflets in the EU (and implemented in UK through the Human Medicines Regulations) for medicinal products are stipulated in Directive 2001/83/EC.
Regulink provides a package leaflet user testing service, which includes assistance with design and layout of patient information according to the relevant regulatory and technical requirements. This involves an initial review and editing phase, development of testing protocols and questionnaire, volunteer recruitment, interviewing, further editing as required and the generation of a submission-ready report. Bridging analysis, focus testing strategy can also be developed to reduce the overall testing burden for our clients.
We also support in the preparation or review of company core safety information (CCSI) and company core data sheets (CCDS), as the basis for SmPC and labelling documentation in Europe, UK and US, as well as educational materials, if required, as part of a Company’s risk minimisation activities.
